On May 20, the state council decided to make changes to the regulations on the supervision and administration of medical devices. 

 

Article 18 is revised as: "in the clinical trials of medical equipment, shall be in accordance with the requirements for the quality control standard for clinical trials of medical apparatus and instruments, in the clinical test units have the corresponding condition, and clinical trials to forward the local people's governments of provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department for the record. Clinical trials for the record of the food and drug supervision and administration department shall inform the clinical test units for the record the location of the food and drug supervision and administration departments at the same level and health departments of family planning. 

 

"A filing management of medical device clinical trials. Medical instrument clinical trial institution shall meet the conditions and for the record management methods and quality control standard for clinical trials, by the food and drug supervision and administration department under the state council jointly with the departments of family planning of public health under the state council and promulgated." 

 

2, paragraph 1 of article 34, the second paragraph, as the first paragraph: "medical apparatus and instruments and the using unit shall have to use medical device type, quantity and conditions appropriate to the storage places. Medical equipment use units shall strengthen the technical training of staff, according to the product specification, technical operation standard requires the use of medical equipment, etc." 

 

Increase a, as the second paragraph: "use unit configuration of large medical equipment, medical devices shall comply with the family planning departments of health under the state council of the large medical equipment allocation planning, and its function orientation, clinical service requirements, with corresponding technical conditions, supporting facilities and have corresponding qualifications and ability of professional and technical personnel, and approved by the family planning departments of health under the people's government at or above the provincial level, large medical equipment allocation license." 

 

Increase a, as the third paragraph: "measures for the management of large medical equipment allocation by family planning departments of public health under the state council jointly with the relevant departments under the state council. Large medical equipment directory by the department in charge of family planning of public health under the state council put forward the relevant departments of the state council, executed after the approval of the state council." 

 

3, paragraph 1 of article 56, in the second paragraph to merge, as the first paragraph: "the food and drug supervision and administration department should strengthen the medical device manufacturing enterprise production and management, and use the unit of medical apparatus and instruments used random inspection. Inspection fee and any other fees may be charged on random inspection, the costs into the government budget at the corresponding level. The people's government at or above the provincial level the food and drug supervision and administration department shall, according to random inspection conclusion medical instrument quality announcement in a timely manner." 

 

Increase a, as the second paragraph: "family planning departments for public health shall exercise supervision over the use of large medical equipment status and evaluation; found illegal use and associated with large medical equipment such as excessive examination, excessive treatment, should immediately correct, dealt with in accordance with the law." 

 

Increase a 4, article sixty-three, as the third paragraph: "without the permission of use of large medical equipment configuration, by the family planning departments of health under the people's government at or above the county level shall be ordered to stop the use, given a warning and confiscate the illegal income; the illegal income of less than 10000 yuan, and be fined between RMB 10000 yuan and 10000 yuan; the illegal income of 10000 yuan of above, and be fined five times more than 10 times the illegal income; if the circumstances are serious, don't accept those responsible for five years and units of large medical equipment allocation licensing applications." 

 

5, paragraph 1 of article sixty-four is revised as follows: "to provide false information or take other deception to obtain registration certificate of medical equipment, medical equipment production license, medical equipment business licenses, large medical equipment allocation license, advertising and other documents of approval certificates, revoked certificates which have been obtained by the original license issuing department, and be fined between RMB 50000 yuan and 50000 yuan, not to accept the relevant responsible persons and units within five years of medical equipment licensing applications." 

 

Increase a 6, article sixty-six, as the second paragraph: "the medical equipment management enterprise, the use of units to fulfil the obligations such as the incoming inspection of these regulations, have sufficient evidence to prove that they don't know the management, use of medical apparatus and instruments for the first paragraph of the preceding paragraph, paragraph 3 cases of medical apparatus and instruments, and can truthfully explain the source of replenish onr's stock, may be exempted from punishment, but shall confiscate its management, use, do not conform to the legal requirements of medical devices." 

 

Increase a 7, article sixty-eight, item 9 as: "(9) medical devices unit using illegal use of large medical equipment, cannot guarantee medical quality and safety", and change the original item 9 to 10 items. 

 

Eight, the article sixty-nine is revised as follows: "in violation of the provisions of these regulations to carry out medical device clinical trials, by the people's governments at or above the county level to the food and drug supervision and administration department shall be ordered to correct or stop clinical trials, to a fine of less than RMB 50000; thereby causing serious consequences, in accordance with the law, the person in charge directly responsible and other persons directly responsible for demoted, dismissed or expelled disposition; the agency may not conduct within five years relevant professional medical device clinical trials. 

 

"Medical device clinical test units issued a false report, by the people's governments at or above the county level to the food and drug supervision and administration department shall be imposed a penalty fine not exceeding 50000 yuan and 100000 yuan; have the illegal income, confiscate the illegal income; the person in charge directly responsible and other directly responsible personnel, given sacked or kicked out of the sanctions according to law; the 10 years may not conduct relevant professional medical device clinical trials." 

 

Nine, the article seventy-three is revised as follows: "the food and drug supervision and administration department, health department in charge of family planning and their personnel shall strictly in accordance with the provisions of these regulations, amplitude, and the types of the punishment according to the circumstances of the nature of the illegal act and the specific exercise of administrative punishment, the specific measures by the food and drug supervision and administration department under the state council, the department in charge of family planning according to their respective duties of public health." 

 

10 and article seventy-six increase: "large medical equipment, is refers to the use of the complex technology, large net inflow, high operation cost, large impact on the health care costs and included in the directory management of large medical equipment." 

 

This decision shall go into effect as of the date of promulgation. 

 

The regulations on the supervision and administration of medical devices shall be revised in accordance with this decision and shall be republished.